Claims for Patent: 4,496,537

✉ Email this page to a colleague

Summary for Patent: 4,496,537

Title:	Biologically stable alpha-interferon formulations
Abstract:	The addition of glycine or alanine prior to lyophilization significantly improves the biological stability of alpha type interferon formulations.
Inventor(s):	Kwan; Henry K. (Summit, NJ)
Assignee:	Schering Corporation (Madison, NJ)
Application Number:	06/532,886
Patent Claims:	1. In a method for preparing a formulation of high specific activity alpha-type interferon having improved biological stability by lyophilizing a solution containing said alpha-type interferon to yield a reconstitutable lyophylizate, the improvement for further increasing said biological stability to a level such that the lyophilizate substantially retains its biological activity even when stored at 20.degree. C. for at least six months which comprises: adding to said solution prior to lyophilization (a) a compatible buffer which will maintain the pH of the reconstituted solution within the range of about 6.5 to 8.0, and (b) glycine or alanine in an amount of 5 to 150 milligrams per milliliter of water to be added for reconstitution. 2. A method according to claim 1 wherein said solution to be lyophilized additionally contains up to 10 milligrams of human albumin for each milliliter of water that will be added during reconstitution. 3. A method according to claim 1 wherein the said alpha type interferon is alpha-2 interferon. 4. A method according to claim 1 wherein said compatible buffer maintains a pH at about 7.0 to 7.4 in the reconstituted solution. 5. A method according to claim 3 wherein about 5 to 25 mg of glycine is added for each 1.times.10.sup.4 to 5.times.10.sup.8 I.U. of the alpha-2 interferon mixture to be lyophilized. 6. A method according to claim 3 wherein about 5 to 25 mg of alanine is added for each 1.times.10.sup.4 to 5.times.10.sup.8 I.U. of the alpha-2 interferon mixture to be lyophilized. 7. A method according to claim 1 wherein the said alpha type interferon is alpha-1 interferon.

Details for Patent 4,496,537

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	June 04, 1986	⤷ Sign Up	2002-11-19
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		⤷ Sign Up	2002-11-19
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132		⤷ Sign Up	2002-11-19
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 4,496,537

Subscribe to access the full database, or Sign Up
Country	Patent Number	Estimated Expiration
Austria	12073	⤷ Sign Up
Australia	558966	⤷ Sign Up
Australia	9168882	⤷ Sign Up
Canada	1207665	⤷ Sign Up
Germany	3262575	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.